Flumazenil Pregnancy and Breastfeeding Warnings

Flumazenil Pregnancy Warnings

Animal studies showed no teratogenicity when given during organogenesis at up to 600 times the human exposure, however embryocidal effects (increased pre- and post-implantation losses) were seen in one animal model at 200 times the maximum recommended human exposure (the non-effect dose in this model was 60 times the human exposure). There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.